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A Phase II Single Arm Study of Degarelix in Men With Castrate Resistant Prostate Cancer With a Rising Prostate-Specific Antigen (PSA) Despite LHRH Agonist Therapy.


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Neoplasm

Thank you

Trial Information

A Phase II Single Arm Study of Degarelix in Men With Castrate Resistant Prostate Cancer With a Rising Prostate-Specific Antigen (PSA) Despite LHRH Agonist Therapy.


To determine the proportion of patients with castrate resistant Prostate Cancer who have a
PSA decline of ≥50% from baseline PSA when switched from an LHRH agonist to an LHRH
antagonist.


Inclusion Criteria:



- histologically confirmed adenocarcinoma of the prostate

- currently receiving LHRH agonist

- Anti-androgen oral therapy is permitted but will be discontinued upon enrollment

- PSA > 2 ng/ml

- rising PSA despite LHRH agonist

- patients may or may not have clinical evidence off metastases. If metastases are
present, they must be asymptomatic and in bone or lymph node only

- Prior chemotherapy allowed

- ECOG performance status 0-1

Exclusion Criteria:

- Patients with a history of other active malignancies, except: adequately treated
non-melanoma skin cancer, superficial bladder cancer, or other solid tumours
curatively treated with no evidence of disease for ≥ 3 years.

- Other serious illness, psychiatric or medical condition that would not permit the
patient to be managed according to the protocol including: i)Significant
cardiovascular condition including but not limited to: uncontrolled hypertension,
unstable angina, significant congestive heart failure or myocardial infarction, deep
venous thrombosis, pulmonary embolus or cerebrovascular attack within the last 6
months. ii) History of significant neurological disorder that would impair the
ability to obtain consent

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

50% fall in PSA

Outcome Description:

Proportion of patients with castrate resistant prostate cancer (CRPC) who have a PSA decline of ≥50% from baseline when switched from an LHRH agonist to an LHRH antagonist

Outcome Time Frame:

8 weekly

Safety Issue:

No

Principal Investigator

Kim N Chi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

British Columbia Cancer Agency, Univeristy of British Columbia

Authority:

Canada: Ethics Review Committee

Study ID:

BCCA_Deg01

NCT ID:

NCT01630967

Start Date:

August 2012

Completion Date:

December 2013

Related Keywords:

  • Prostate Neoplasm
  • castrate resistance
  • PSA progression
  • LHRH antagonism
  • Neoplasms
  • Prostatic Neoplasms

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